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A multi-center, double-blind, placebo parallel controlled clinical study of Changjiling in the treatment of diarrheal irritable bowel syndrome with anxiety and depression

A multi-center, double-blind, placebo parallel controlled clinical study of Changjiling in the treatment of diarrheal irritable bowel syndrome with anxiety and depression

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003524
Enrollment
Unknown
Registered
2020-07-30
Start date
2020-07-27
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable bowel syndrome

Interventions

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. It meets the diagnostic criteria of Western medicine for IBS and the type is diarrhea-based; 2. Patients with syndrome of liver depression and spleen deficiency in TCM differentiation; 3. Those who are rated as mild or moderate by IBS-SSS disease severity, that is, the IBS-SSS score is 76-300; 4. Patients with mild or moderate depression or anxiety evaluated by GAD-7 or PHQ-9, that is, those who have a total score of 5-15 for GAD-7 or 5-13 for PHQ-9; 5. Those who are willing to sign an informed consent; 6. Age between 18 and 70 years old; 7. Normal cognitive function, no literacy barriers; able to actively cooperate and participate in investigation and research.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or preparing to become pregnant, and breastfeeding women; 2. Intestinal organic diseases, such as inflammatory bowel disease, intestinal tuberculosis, colon polyps; 3. Patients with severe cardiovascular and cerebrovascular system, liver, kidney, hematopoietic system diseases and tumors; 4. There is a record report of digestive tract surgery; 5. Patients with severe primary diseases and mental illnesses; 6. Patients who have taken psychiatric drugs, sleeping pills, anticholinergics, hormones, non-steroidal anti-inflammatory drugs and other drugs in the past 2 weeks, and received psychobehavioral therapy; 7. Patients with a history of allergy to related drugs used in this research; 8. Test results during the screening period showed that the ALT and AST values ??exceeded the upper limit of the normal range by 2 times, and the total bilirubin and BUN values ??exceeded the upper limit of the normal range by 1.5 times.

Design outcomes

Primary

MeasureTime frame
AR response rate;

Secondary

MeasureTime frame
Improvement of stool characteristics;PHQ-9;GAD-7;PSQI;IBS-QOL;TCM syndrome curative effect;

Countries

China

Contacts

Public ContactHuang Shaogang

Guangdong Hospital of Traditional Chinese Medicine

huangshaogang@126.com+86 20-39318991

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026